Dr. Reddy’s Laboratories has received two FDA Form 483s in the past month for two different facilities, making a total of at least seven forms sent to the company in the past year.
The two open Form 483s relate to two Dr. Reddy’s sites in the southeast Indian state of Andhra Pradesh, after inspections made in May and June.
“None of our plants are under Official Action Indicated (OAI), Warning Letter (WL) or any sort of escalation. All of them maintain a state of compliance,” a spokesperson for Dr. Reddy’s told Endpoints News in an email.
The latest inspection made between May 30 and June 7 at its API manufacturing site in Srikakulam resulted in four observations, according to the Form 483 published on the FDA’s site Thursday.
The FDA said the manufacturer failed to properly validate at least 30 analytical tools used to test the quality of commercial APIs before they were to be distributed to customers for drug manufacturing. These APIs are still in the market, and Dr. Reddy’s has received one customer complaint for APIs without certain specifications.
Dr. Reddy’s also failed to explain discrepancies in API batches. The inspectors found the site’s quality control unit did not properly test all APIs, such as failing to test particle size distribution, before shipping to the US.
In a separate inspection from May 8 to May 17, the FDA also visited a formulation facility in Visakhapatnam that resulted in two observations, according to a Dr. Reddy’s press release. It did not detail the agency’s observations.
Last year, Dr. Reddy’s received at least five Form 483s from the FDA, the company told Endpoints. One was issued after an October inspection and another in a December visit for two separate facilities. These five forms are closed.
Dr. Reddy’s manufacturers biologics, generics and APIs for oncology and cardiovascular therapies, among others.